Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter— 510(k) K151368

Substantially Equivalent

Terumo Bct

FDA 510(k) clearance K151368 for Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter, Substantially Equivalent on 2015-09-11. Applicant: Terumo Bct.

Clearance details

Applicant: Terumo Bct
Product code: Code LKN
Advisory panel: Unknown
Date received: 2015-05-21
Decision date: 2015-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.